Since the publication of the Uniform Guidance UG), institutions have seen various Conflict of Interest (COI) terms and conditions embedded within broad agency announcements and proposal solicitations, despite the lack of formal agency-wide policies or guidelines in most cases. The specific requirements for what financial interests and relationships need to be disclosed, the nature and timing of reviews, and even definitions such as “conflict of interest” and “immediate family member” are unclear and/or vary slightly from one agency to another, making it more complex to administratively handle and more difficult to ensure compliance in each case. Additionally, many of these terms and conditions require COI certifications at the time of proposal submission as to whether or not a COI exists and if so, how the COI will be mitigated if the proposal is funded.
We strongly urge the federal agencies to harmonize COI requirements, particularly relative to policy scope, definitions, timing of COI reviews and determinations, and reporting requirements, in order to provide consistency across agencies and thereby reduce administrative burden. Given that the vast majority of research proposals are not funded, we specifically urge federal agencies to adopt the Public Health Service (PHS) timing for COI reviews and determinations (at the time of award/prior to expenditure of funds), rather than prior to proposal submission. A review of every potential COI for each research proposal submitted rather than a review relative to each research project actually funded constitutes a much higher burden on applicant institutions. Allowing COI reviews and determinations to occur at time of award would be more consistent with the policies and procedures institutions have already had to implement to comply with PHS’s 42 CFR § 50, an implementation that cost an average of $318,000 per institution according to the Association of American Medical Colleges COI Metrics Project*.
Finally, the UG calls for each agency to promulgate COI policies related to procurement, not research integrity. However, there is a lack of both clarity and consensus among institutions as to the focus of the COI provisions of the UG, and it appears these two types of COI have been conflated by agencies and institutions in the process of implementation. We request that federal agencies clearly establish and specifically articulate what types of terms and conditions or policies are required, and provide clarification to institutions on whether such requirements apply only to procurement arrangements and actions or are meant to address the potential for research integrity considerations as well.